Model Number 304-20Event Date 04/07/2015Event Type Injury Event Description It was reported on (b)(6) 2015 from the patient who reported a painful red lump having appeared on his neck within the last few months. The patient was implanted in (b)(6) 2014. The patient stated that the area looks kind of infected and has a large knot on it. He reported pain at the site and redness on the mass. It was recommended he contact his physician or surgeon regarding the issue. Follow-up with his physician showed that the patient did not show for two of his scheduled appointments. Therefore, no additional information has been obtained.

Manufacturer Narrative Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Model Number 304-20Device Problem Adverse Event Without Identified Device or Use ProblemEvent Date 06/04/2015Event Type Injury Event DescriptionIt was reported that the patient was seen in the clinic and had a fever since implantation. The neurologist was not sure if the fever was related to implantation and referred the patient to the surgeon. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

Event DescriptionIt was reported that the vns patient had a seizure which may have opened up the electrode incision site on the neck. The patient was experiencing pain in this area. Additional information was received stating that the patient was hospitalized due to an increase in seizures. It was noted that patient had a high temperature which may have contributed to the increase in seizures. No further information relevant to the event has been received to date.

Event DescriptionOn (b)(6) 2015 the physician's office reported that the patient was scheduled to see the physician but missed her appointment. The assistant stated that the patient was indeed referred for an ultrasound but the assistant stated she sees no indication that the patient had that done. She said that the patient cancelled her appointment with the physician and has not rescheduled any appointment.

Manufacturer Narrative(b)(4).

Event DescriptionThe patient reported on (b)(6) 2015 that after implant surgery she had an infection and sepsis. As a result, she had to spend a few weeks in the hospital. The issue was associated with her implant wound. Since then she has developed a "squishy lump area" on her chest, above the generator. The patient noted that she left the surgery receiving stimulation. Following her first titration she began to feel severe pain in her throat and her ear. She describes it as feeling "like stabbing". The generator had been turned from output=0. 50ma up to 0. 75ma when this issue began. She reported that the neurologist refused to turn her therapy level down upon her request and therefore she was upset with him. The patient again reported severe, unrelenting ear and throat pain with vns stimulation. She said she saw her primary care physician and he told her that she does not have an ear or throat infection or reason for the pain other than her vns stimulation. The patient saw her surgeon and they turned the stimulation down from output= 0. 75ma to 0. 5ma as requested by the patient. The nurse practitioner said that this helped the patient's comfort. The patient wanted to keep the device implanted. The physician ordered some blood work and an ultrasound to make sure that there was no infection. Diagnostics were ok at 3174 ohms.

Model Number 102Event Date 01/01/2015Event Type Injury Event DescriptionIt was reported that the patient is scheduled for vns removal surgery due to not being able to tolerate stimulation and the generator causing discomfort. No additional relevant information has been obtained to date.

Event DescriptionAdditional information was received that the patient is still reporting the device is not working and also that it is causing pain. Available programming history for this patient was reviewed and revealed normal diagnostics up through (b)(6) 2007. A battery life calculation was performed with the available programming history. The result revealed 2. 0 years remaining until near end of service flag = yes. It was reported that the patient believes that some other external device shorted the vns system, although clarification on this point could not be obtained. When the patient's vns generator was interrogated, it showed that the device was set to 0. 0ma output current. No additional relevant information has been obtained to date. No known surgical interventions have occurred to date.

Event DescriptionIt was reported that the patient was requesting explant of her vns device because she believed it was no longer working. No additional relevant information ahs been received to date.

Model Number 304-20Event Date 06/01/2015Event Type Injury Event DescriptionIt was reported that the patient will be having a lead revision and a possible lysis of adhesions due to pain. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

Model Number 102Event Date 06/01/2015Event Type Injury Event Description It was reported that the patient's vns needs to be replaced as she still has pain in her neck and upper chest area. It was also reported that the patient had a vns generator replacement that occurred on (b)(6) 2015. Good faith attempts for additional, relevant information have been unsuccessful to date.

Event Description It was reported that the device was discarded and cannot be returned for evaluation.

Event Description The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description It was reported that the patient was experiencing pain in the throat that radiates up to his ear and a painful pulling sensation when leaning since (b)(6) 2014. The patient suffers falls with seizures, but no known trauma occurred. It was reported that the patient had grown significantly since vns implant. Device diagnostics were within normal limits and the device was programmed off. The patient's mother would like the device explanted. It was later reported that the patient underwent vns explant. The explanted devices have not been received for analysis to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description Information was received from the neurosurgeon. He stated that the patient's generator was explanted because his parents wanted it removed. The parents said it was shocking the patient. The lead was also explanted. The generator and lead were not replaced.

Event Description It was reported that the patient would like the vns device explanted due to swelling in the area of the generator and extreme pain in the left side of the neck and jaw. It was noted that the pain increased when the vns device was stimulating; therefore, the vns device was programmed off sometime in 2008. No known surgical interventions have been performed to date.

Event Description It was further reported that the patient has decided not to have her vns explanted at this time.

Model Number 104Event Date 06/15/2015Event Type Injury Event Description Additional information obtained from the surgeon indicates that the cause of the generator migration is unknown but may have been related to the substance he observed around the generator, which he believed to be infected tissue, when he opened the pocket. The surgeon stated there was no manipulation or trauma that he was aware of and the patient did not appear to be a twiddler. He stated that non-absorbable sutures were used to secure the generator during its implant. He stated the planned intervention to reposition the device was for patient comfort but the intra-operative removal was deemed appropriate given the finding of what he thought to be signs of an infection. The generator and all but one inch of the electrode portion of the lead were explanted.

Manufacturer Narrative

Event Description It was reported that a vns patient would have his device repositioned to address pain caused by generator migration. Clinic notes obtained indicated that the patient¿s treating neurologist noted pain and tenderness at the vns site and stated that the generator had migrated towards the sternum. The patient¿s vns system was tested and showed normal device function. The patient¿s surgeon described that the generator had shifted medially on his chest and overlies the costosternal border, it was uncomfortable with no redness, swelling, inflammation, open wounds, or drainage and that the patient¿s pain was exacerbated by pushing on that area. It was subsequently reported that during the repositioning surgery the surgeon explanted the generator and the lead (electrodes remaining) due to infection. Attempts for additional relevant information have been unsuccessful to date. The reported infection is reported in mfr. Report #: 1644487-2015-05254.

Model Number 103Event Date 06/01/2015Event Type Injury Event Description It was reported that the patient was scheduled for vns revision because the generator had migrated and is causing the patient pain. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

Model Number 304-20Device Problem Insufficient Information Event Date 05/15/2015Event Type Injury Event Description It was reported that the patient was seen by the ent and diagnosed with left vocal cord paralysis and will not need a vns revision. It was reported that the vocal cord paralysis may be temporary. The patient is doing physical therapy for the vocal cord paralysis and the ent reported that the neurologist should be able to start ramping up the patient's vns therapy.

Manufacturer Narrative

Event Description Initially, it was reported that the patient had a constant cough and she was unable to eat. It was also reported that the patient had no voice from the surgery but has improved. The patient's generator had not yet been programmed on. It was later reported that the physician met with the patient and the patient's voice was better and the coughing was also improving. The patient's generator has not yet been programmed on. Later it was reported that the patient is having discomfort where the leads are presumably when she turned her neck towards the right. It was also stated that the turning motion, with the device off, prompts coughing. The patient was seen again and reported that the generator site was tender. The generator was protruding, but has not extruded through the skin. Due to the complaints of pain at the electrode site and the generator site, coughing to the point of vomiting, and voice alteration, exploratory surgery was performed. The surgeon ran diagnostics with the lead in multiple positions and all measurements were within the acceptable range. The surgeon redid the strain relief loop and tie downs. After the surgery, it was reported by the physician that the coughing had been resolved and the patient's voice is almost back to normal. The pain in the area of the generator was attributed to the scar related to the vicryl suture. The patient's generator has not yet been programmed on, but the patient is once again complaining of voice changes and tightness when turning the neck towards the opposite side previously reported. The patient was referred to an ent for evaluation. No additional relevant information has been received to date.

Manufacturer Narrative (b)(4). This information was inadvertently left off of the initial mfr. Report.

Model Number 300-20Device Problems Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected Event Date 06/25/2015Event Type Malfunction Event Description It was reported that the patient¿s device was turned off for mri on (b)(6) 2015, and turned back on on (b)(6) 2015. At this time the pulse width was increased from 250 to 500. Around 5:30 am on(b)(6) 2015, the patient could not speak or stick out her tongue, and appeared to be in much pain. Device was turned off again and it helped for a while but the issues did not resolve. System diagnostics show result of high impedance. It was also mentioned that the patient recently underwent craniotomy 3 days prior to (b)(6) 2015.

Manufacturer Narrative Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description Additional information was received that the high impedance was first observed on (b)(6) 2015 and was not observed prior to that. Patient was referred for lead revision and prophylactic generator replacement but no surgical interventions have occurred to date.

Event Description Additional information was received that the patient underwent surgery on (b)(6) 2015. It was reported that the patient's implanted generator and lead were not removed as the surgeon did not want to create a new scar. Instead, the surgeon implanted a new vns generator and lead on the right side of the patient. The lead was implanted on the right vagal nerve. The patient and family agreed with the surgeon and therefore the old devices were not touched. The surgeon was informed of the cardiac risks of implanting vns system on the right side. The neurologist was also made aware of the two systems implanted in patient and that the system on the left will show high impedance as this was not corrected. Neither the patient nor the surgeon at this time feels that it is necessary to remove the suspect device.

Event Description The patient underwent generator replacement due to end of service. The explanting facility has policy of not returning explanted devices; therefore, no product analysis can be performed.

Event Description Clinic notes dated (b)(6) 2015 note that the patient has had many more seizures in the last month than previously. The battery level was noted to be 1/3. Device settings were adjusted and it was recommended for the patient to do prophylactic magnet swipes every four hours since the seizures have become more significant with more pain. It was reported that the increase in seizures was above the patient's pre-vns baseline frequency. The device was rechecked on (b)(6) 2015. It was reported that since the patient is using the magnet prophylactically the battery is being consumed faster. The patient will be referred for generator replacement. No known surgical interventions have been performed to date.

Model Number 102Device Problem High Test Results Event Date 05/11/2009Event Type Injury Event Description It was reported that the patient has experienced ear pain with higher levels of device stimulation since generator and lead replacement in 2009. The patient underwent generator and lead replacement due to the pain on (b)(6) 2015. The explanted devices have not been received for analysis to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description The patient's mother reported on (b)(6) 2015 that the pain has gotten to the point where she can no longer eat. She wants the vns removed. It was reported on (b)(6) 2015 that the patient had a mass on her neck and pain when turning her head due to the mass. The patient was referred for x-rays. Follow up with the patient's caretaker on (b)(6) 2015 indicated that the mass on the patient's neck was determined to be the tie-down. The patient was losing weight due to an increased dosage of topamax, so the tie-down has become visible and likely also caused the neck discomfort from the lead occurring for about 18 months. The patient also experienced constant difficulty swallowing which the caretaker believed is related to the position of the lead. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician have been unsuccessful.

Event Description Additional information was received that the patient is not eating due to discomfort form vns. X-rays were taken which revealed no issues.

Manufacturer Narrative Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the information about the x-ray review and continued discomfort and weight loss issues.

Event Description It was reported that the patient experiences a difficult time tolerating device settings increases and then collapses. It was reported that it takes the patient 2-3 days to no longer feel pain following the increase in settings and that the patient becomes accustomed to the device stimulation after about 3 days. The patient is trying to find a new vns physician. No additional relevant information has been received to date.

Model Number 302-20Device Problem Break Event Date 05/18/2015Event Type Injury Event Description Analysis of the returned lead portion was completed. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted and there was no evidence to suggest an anomaly with the returned portions of the device. Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Event Description It was reported that the vns patient underwent surgery on (b)(6) 2015 to explant her device due to pain. Review of the available programming and diagnostic history showed that the patient's device was disabled on (b)(6) 2009 and was never ramped up to a output current greater than 0. 75ma prior to disablement. The explanted generator and lead were returned to the manufacturer for analysis. The generator septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. Analysis of the lead is currently underway.

Model Number 102Device Problem Adverse Event Without Identified Device or Use Problem Event Date 11/01/2014Event Type Injury Event Description Additional information was received that the patient underwent generator and lead explant surgery on (b)(6) 2015 due to the pain and migration. The surgeon noticed that the generator appeared to still be held in place by a non-absorbable suture, but it was lose and was removed without cutting the suture. The surgeon reported that it did not appear the generator had slipped in the pocket based on the suture still in place. The explants were discarded.

Manufacturer Narrative

Event Description It was reported that the patient was in clinic back in (b)(6) with chest pain. The patient has had recent x-rays and the radiologist said that the device had moved down under the armpit and is pushing on a nerve which now causes pain in the patient's neck. The generator battery was reported to have reached end of service sometime in 2013. A battery life calculation was performed with the available data and assumptions were made for any gaps found if present. The result revealed 0. 0 years remaining until eri = yes. Additional information was received that the patient's device was unable to be interrogated in (b)(6) 2015 due to end of service. The pain had been occurring for the previous 6 months. No additional relevant information has been obtained to date.

Manufacturer Narrative Date received by manufacturer (mo/day/yr): the previously submitted mdr inadvertently provided the wrong date of awareness for supplemental information. It was known since (b)(6) 2015 that the patient was scheduled for surgery.

Model Number 103Device Problem Migration or Expulsion of Device Event Date 09/03/2015Event Type Injury Event Description The patient did not have her surgery has scheduled. The patient has had medication issues which were a factor in the decision not to perform surgery. No additional relevant information has been received to date.

Event Description Patient underwent generator replacement surgery. The explanted generator has not been received to date.

Event Description It was reported on (b)(6) 2015 the patient had come in the day prior and was complaining of radial arm pain. The vns device was interrogated and system diagnostics were run and everything was fine. It was discussed that the patient had lost over (b)(6) lbs since implantation and the device has moved medially. It is right on her chest bone now. The physician thinks that her arm pain might be due to the device moving and putting pressure on a nerve. He is referring her to a neurosurgeon for a revision of the placement of the generator. No additional relevant information has been received to date.

Manufacturer Narrative

Event Description Additional information was received that patient is having her device revised due to the fact that the patient has lost weight and the device has migrated. It was also reported the patient is feeling pain and choking during stimulation.

Model Number 102Device Problem Device Operates Differently Than Expected Event Date 09/05/2015Event Type Malfunction Event Description Information was later received that near the time of the initial event, the patient was undergoing a procedure unrelated to vns when an anesthesiologist noticed some spots on her throat and referred her to an ent physician. The patient saw the ent physician sometime near (b)(6) 2015 and noticed that her vocal cords were not opening or closing like they were supposed to. Patient did not have any symptoms from this event. The ent physician did not take any intervention for this and told patient to come back in 6 months for a checkup. Additional relevant information has not been received to-date.

Manufacturer Narrative

Event Description The patient had generator replacement on (b)(6) 2015 due to pain. The explanted device was received by the manufacturer. However, analysis has not been completed to date.

Event Description It was reported that a patient was experiencing erratic stimulation constantly and tingling pain at neck/clavicle area. Diagnostics were performed and were within normal limits. The patient¿s generator was programmed off, but the pain persisted. The (b)(6) wants the device replaced due to the issue. The device remained programmed off. Per clinic notes from (b)(6) when the patient followed-up with her physician, the patient was seen in the hospital with pain in her neck and throat. The device stimulation caused ¿intense pain¿ in her throat. The patient was unable to speak and felt as if the device was ¿squeezing¿ her throat. After the device was programmed off, the patient reported that the squeezing sensation in her throat became ¿unacceptable stinging in the left neck¿. The magnet was taped to the patient in the hospital to stop the stimulation, but was unsuccessful.

Event Description Analysis was completed on the generator. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. There were no performance or any other type of adverse conditions found with the pulse generator.

Model Number 102Device Problem Adverse Event Without Identified Device or Use Problem Event Type Injury Event Description Analysis of the generator was completed on 10/29/2015. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition. Analysis of the lead was completed on 11/06/2015. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative

Event Description It was reported that a patient's vns generator was explanted. The patient felt vns was making her seizures worse and was causing her pain in the neck. It is unknown if this pain was associated with stimulation. The patient also felt that vns did not help her seizures. Attempts for additional relevant information have been unsuccessful to date. The explanted generator has not been returned to the manufacturer for analysis to date.

Event Description Further follow-up revealed that the physician indicated the increase in seizures was not related to vns. The seizures were not an increase above the patient's pre-vns baseline frequency. Clinic notes on (b)(6) 2015 note that the patient would like her vns removed because it is more trouble than it's worth. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

Model Number 302-20Device Problem High impedance Event Date 02/05/2019Event Type Malfunction Event Description It was reported that the patient had high impedance at their appointment. The patient had reportedly heard a pop and felt vibrations in their neck that had since resolved. The patient later reported that they had felt pain in their neck and chest. Per the patient, no trauma had recently occurred to the neck or chest. Surgery is likely but has not occurred to date. No additional information has been received to date.

Model Number 106Device Problem Adverse Event Without Identified Device or Use Problem Event Date 01/17/2019Event Type Injury Event Description Report received from clinic notes indicated that a patient underwent surgery due the generator causing pain and sticking out. The generator was not replaced, but sewn down. No other relevant information has been received to date.

Model Number 105Device Problem Migration or Expulsion of Device Event Date 05/01/2015Event Type Injury Event Description On (b)(6) 2015 it was reported that the patient's generator migrated into the lower ribcage area and the patient was complaining of tightness in the neck. Diagnostics were good. Clinic notes were received on (b)(6) 2015 which indicated the patient is having swelling on the left side of her neck, along the vns leads. It was also noted that the vns generator has a palpable edge that is causing the patient pain. The physician noted that the patient has grown two cup sizes since the vns was implanted. The patient feels that a revision is justified based on her current level of discomfort. The patient underwent a generator pocket revision surgery on (b)(6) 2015. Good faith attempts for further information from the physician were unsuccessful.

Event Description The physician confirmed that a non-absorbable suture was used to secure the generator during implant.

Model Number 105Event Date 01/01/2015Event Type Injury Event Description It was reported by the physician the patient had her generator and lead explanted on (b)(6) 2015 due to painful stimulation at the generator site. It was also reported the patient had pain in her left neck at the incision site. It was reported the patient first began having pain around (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date.

Model Number 103Event Date 08/12/2015Event Type Malfunction Event Description It was reported that the patient does not feel that the vns is working. The patient cannot feel stimulation when she swipes the magnet. The patient feels that the device has been acting "funny" for several weeks. The patient had two seizures on (b)(6) 2015, which was reportedly an increase in seizures so the patient went to the er. While at the er, it was reported that the patient's vns was not working at all. The er was unable to locate the vns generator with the wand and an x-ray had to be done to locate it. Additional information as received that the patient feels her vns stimulating erratically, and it is somewhat painful. The patient can still not feel magnet swipes. 2 magnets have been used without success. The patient also is complaining of tiredness and seems "twitchy. " no additional relevant information has been obtained to date.

Model Number 304-20Device Problems High impedance; Moisture or Humidity Problem; Lead Event Date 01/01/2015Event Type Malfunction Event Description It was reported that the patient has neck pain. The impedance values were not obtained at the follow-up appointment on (b)(6) 2015, but it was known that after implantation surgery on (b)(6) 2015 the value was around 4000 ohms but then they disabled the device and did not want to turn it back on to run diagnostics and check impedance apparently. The patient was referred for prophylactic replacement due to the pain (burning sensation). It was found that since the impedance was on the higher side (4000 ohms) the patient's family wanted to replace the lead prophylactically. During the replacement surgery on (b)(6) 2015 the surgeon found fluid in the lead. The explanted lead has not been received for analysis to date.

Event Description Clinic notes received on (b)(6) 2015 reported that the lead impedance with the explanted m103 device was 4600 ohms which is again on the higher end. It appears that the allegation against the lead was present with the explanted 103 device and the m106 device. Therefore the issue was likely present prior to (b)(6) 2015 but the exact date in 2015 is unknown. The explanted lead was received for analysis on (b)(6) 2015. Product analysis is underway but has not been completed to date.

Event Description Product analysis for the m106 generator was complete and approved on 12/28/2015. Product analysis for the 304-20 lead was completed and approved on 01/07/2016. From analysis it appears that the generator was disabled prior to explant. There was no high impedance seen on the generator based on the generator data dump and diagnostics run at implantation on (b)(6) 2015. Analysis on the lead has identified fluids inside the outer tubing in some areas. The abraded openings in the outer tubing that provided the leakage path for the dried remnants of body fluids were attributed to the explant process. Analysis identified a stress induced fracture (rotational forces likely from explant) on the electrode. They also observed pitting on the coil surface and state that a couple of strand break occurred while stimulation was present (so prior to disablement and explant) due to the existence of metal pitting on the broken coil surfaces. Evidence of rotational forces on most of the wire ends suggests much of the lead was intact during the implant life and a complete discontinuity was probably a result of the explant procedure. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.

Event Description It was reported that the patient experienced pain when she moves her arm. The physician believes that the generator has migrated laterally and has referred patient for surgical evaluation. Diagnostics were reported to be within normal limits. A non-absorbable suture was used to secure the generator to fascia during implant surgery for this patient on (b)(6) 2015. Additional information was received from the neurologist that the patient experienced pain since approximately early (b)(6) 2015. There was no trauma or other incidents that might have contributed to the migration of the device. The migration is believed to be progressive since implantation or soon after. No known surgical interventions have occurred to date.

Event Description Additional information was received form the surgeon's office that the patient was seen and that the surgeon felt that the device was satisfactorily in place and that no surgical interventions are needed. If patient experiences an erythema again, patient was advised to see the surgeon at that time.

Model Number 304-20Event Date 09/30/2015Event Type Malfunction Event Description It was reported that high impedance was seen during system diagnostics. The physician disabled the patient's generator due to the high impedance. The manufacturing records for the lead was reviewed and the device met all specifications prior to shipment. The physician's office has ordered x-rays but they still have not been performed. They will provide a copy of them to the manufacturer once they are taken.

Event Description In a (b)(6) 2016 appointment, the patient¿s generator had normal mode current turned on. However, the patient then experienced neck pain and coughing with stimulation. The normal mode was turned back off. High impedance was again noted in this appointment. On a subsequent date, chest x-rays were stated to have been performed, and the medical professional assessed that the vns system was intact. No additional pertinent information has been received to date.

Event Description It was reported the patient is experiencing severe pain and dyspnea. The pain was noted to be located at the neck and the generator site. The patient's caregiver is interested in having the device explanted. Settings were lowered, but symptoms did not resolve. The device was programmed off to assess for efficacy. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have been completed to date.

Model Number 103Event Date 05/11/2014Event Type Injury Event Description Following patient's generator replacement surgery on (b)(6) 2015, it was noted that the lead was protruding at the generator site. Clinic notes dated (b)(6) 2015 indicate that the surgeon might perform another surgery to get the wire in better position so that it does not stick up. Other than the lead protrusion, the incision is well healed and there is no sign of infection. Additional information was received from the physician that the patient is a fiddler/picker and that she had twisted the lead at the generator site, which caused the lead to protrude a little. On (b)(6) 2015, the physician readjusted the position of the lead so patient can avoid picking at it and no devices were replaced. It was reported that the surgery was for the comfort of the patient and to reposition it so patient does not pick at it. Notes dated (b)(6) 2015 indicate that the patient's surgery on (b)(6) 2015 was to correct the protrusion of the lead as it was bothersome and painful upon palpitation. During surgery, an egress of old blood clot was noted and was evacuated. The surgeon noted that the generator had turned somewhat. The generator and lead were repositioned to minimize the chance for the lead poking up through the skin. The generator was tested within the pocket and noted to have normal functioning and good impedances.